At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 629 enrolled
Drug / intervention
Fidaxomicin +2 moredrug
Likely dose
Fidaxomicin 200 mg orally twice daily (q12h) for 10 daysAI-extracted
Key inclusion· 1
- ✓Confirmed diagnosis of Clostridium difficile-associated diarrhea (CDAD)
Key exclusion· 5
- ✕Life-threatening CDAD
- ✕Toxic megacolon
- ✕Pregnant or lactating
- ✕Concurrent use of antidiarrheal agents
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-National, Multi-Center, Double-Blind, Randomized, Parallel Group Study to Compare the Safety and Efficacy of 200 mg PAR-101 Taken q12h With 125 mg Vancomycin Taken q6h for Ten Days in Subjects With Clostridium Difficile-Associated Diarrhea
Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)·interventional·Posted Apr 17, 2006·Updated Apr 21, 2017
In Brief
A Phase 3 clinical trial evaluating Fidaxomicin, Vancomycin, and 1 other intervention for Clostridium Infections and Diarrhea. Completed, enrolled 629 participants.
Detailed Summary
This is a comparative study to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-Associated Diarrhea (CDAD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsClostridium Infections, Diarrhea
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 2006
Enrollment StartMay 2006
Primary CompletionJul 2008
Study CompletionAug 2008
TodayJul 2026
First PostedApr 17, 2006
Enrollment StartMay 2, 2006
Primary CompletionJul 23, 2008
Study CompletionAug 21, 2008
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 20.2 years ago
Interventions
Fidaxomicindrug
200 mg oral capsules two times daily (q12h regimen)
Vancomycindrug
125 mg capsules q6hr (4 times a day)
Matching Placebo to Fidaxomicindrug
Matching Placebo to Fidaxomicin administered two times daily (intermittently with fidaxomicin dosing)